The opioid epidemic — prescription and heroin — is persisting as a public health crisis, and medications to treat opioid addiction are increasingly supported by public health authorities. So why is the opioid treatment program (OTP) with its methadone maintenance treatment not getting more attention? We talked to Mark Parrino, president of the American Association for the Treatment of Opioid Dependence (AATOD), a membership organization representing OTPs, to gain some insight.

Parrino has been involved in the OTP field for decades, first as a clinic owner, and then for more than 30 years as head of the trade organization. Over the past 10 years, as many people became addicted to prescription opioids and then transferred to heroin when the prescription medications became harder to get, OTPs seemed the logical solution, as they had been successfully treating opioid dependence with methadone since the 1950s. Because of the 1914 Harrison Narcotics Act, which makes it illegal to treat opioid addiction with an opioid, OTPs are highly regulated.

However, 15 years ago. the federal Drug Addiction Treatment Act (DATA) made it possible for another opioid medication — buprenorphine — to be used to treat opioid addiction, this time with far less regulation than an OTP. Physicians could be waivered from the Harrison Narcotics Act under DATA 2000 to treat up to 30 patients with buprenorphine, prescribing it from their offices, and then up to 100 patients under DATA 2003. The opioid crisis has led to proposed legislation to lift these caps. Parrino has been a vocal force in Washington, D.C., as the Substance Abuse and Mental Health Services Administration (SAMHSA) considers lifting the cap, among other issues.

In addition to the expansion of access to buprenorphine, two other initiatives have had more support already from the federal government and Congress: expanding access to naloxone, especially to first responders, to reverse opioid overdoses, and discouraging physicians from prescribing opioids by requiring them to use prescription drug monitoring programs.

States

The federal government is moving forward to address the opioid crisis, but the state response is “where the rubber meets the road,” Parrino told ADAW last week. “This isn’t about a philosophical challenge,” he said. “The question is, what exactly are we going to do to respond to this issue?”

Parrino said the most complete model of getting people into treatment is Vermont’s hub-and-spoke model, in which all new patients are assessed at the central spoke, where they are then moved to either office-based treatment (in a spoke) with buprenorphine or methadone treatment in an OTP (a hub). He credited Vermont Governor Peter Shumlin with the vision and support to make the hub-and-spoke program work, noting that what makes the program unique is the clinical coordination.

For example, in Vermont, when someone overdoses on opioids and the first responder rescues the person with the naloxone overdose prevention kit, the first responder brings them to the emergency department, which connects them to a treatment program.

In other states, the atmosphere is completely opposed to methadone — such as in Maine, due to the opposition to the medication by the governor. And in many states, there is no public financial support of OTPs.

Medicare and Medicaid

Reimbursement, even in the age of the Affordable Care Act, is not easy for OTPs. In states that don’t provide any funding, including Medicaid funding, for treatment in an OTP, patients typically have to pay for their own treatment out of their pockets. Currently, Parrino is working with the Centers for Medicare & Medicaid Services (CMS) on making it possible for OTPs to bill Medicare for the treatment of Medicare beneficiaries. CMS is being responsive to concerns, he said.

One example is Maryland, where the OTP bills the regional Medicare office, waits for the claim to be denied and then files the claim with the state to be able to access Substance Abuse Prevention and Treatment block grant funds, said Parrino. Sylvia Burwell, the secretary of the Department of Health and Human Services (HHS), is serious about trying to close the treatment gap, Parrino said.

However, Medicaid is far more complicated than Medicare, because about 19 states have absolutely no Medicaid coverage for treatment in an OTP.

Private sector and self-pay

There are 340,000 patients in OTPs across the country. There should be many more, given the number of people with opioid use disorders. But reimbursement problems limit expansion, said Parrino. In fact, the only reason there has been any expansion at all is investment in the private for-profit sector. “You don’t see a similar sort of increase on the public side,” he said. There may be change in the future, however. For example, there is no Medicaid reimbursement for OTPs in Georgia or Tennessee, but after the AATOD conference last spring OTP representatives met with Cassandra Price, the SSA of Georgia who is also the new president of the National Association of State Alcohol and Drug Abuse Directors, said Parrino. “Now, after years of recalcitrance, they are working to develop a Medicaid reimbursement model,” he said.

Expansion is also difficult because of public opposition to OTPs on the part of people who don’t understand methadone. In North Dakota, OTPs are in the process of expanding, but facing NIMBY (not in my back yard) problems. As soon as program operators want to site the facilities, municipalities develop moratoria against any new OTPs, said Parrino.

HRSA

Parrino views the $100 million in treatment funding going to Federally Qualified Health Centers (FQHCs) from the Health Resources and Services Administration (HRSA) as a more focused approach. The funding, announced July 27 by Burwell, would require that some of the money be used for medications to treat opioid use disorders (see ADAW, Aug. 3, Aug. 10). “My sense is that HHS is truly interested in this,” said Parrino. “This is a way of saying to the FQHCs, ‘We want you in the business of treating opioid addiction.’”

The FQHCs could be licensed as OTPs, which would immediately expand capacity, he noted. Or they could train their physicians to provide buprenorphine in the office-based model. What many in the field are hoping is that the FQHCs will prove the medication, and the specialty addiction treatment providers will provide the counseling. There is some concern that the service delivery model will not include counseling, but only medication. “It depends on how the federal government wants to monitor this,” said Parrino. “To some degree, the department wants to increase treatment capacity.” OTPs provide comprehensive services, as required by SAMHSA.

Buprenorphine cap

This leads to the conflict between OTPs and office-based treatment with buprenorphine, which does not carry the counseling requirement or any other requirements of OTPs. The conflict between OTPs and office-based treatment is particularly germane in the current discussion of lifting the patient cap for buprenorphine, now at 100. How the American Society of Addiction Medicine guidelines for medication-assisted treatment mesh with their own policy recommendations for office-based buprenorphine is a “great question,” said Parrino. “You have 100 pages of guidelines saying that clinicians treating addiction using any of these medications should follow these best practices,” he said. “If you’re treating 300 to 500 patients, how do you do this?”

The current crisis — overdoses and addiction — is causing a “fixation on numbers,” said Parrino. In the midst of that crisis, the principles of treatment no longer seem a priority, he said. Treating large numbers of people, even with substandard care, may seem better than not expanding treatment at all.

“I believe that the rapid expansion of methadone treatment in the ’60s and ’70s is to some extent culpable for the stigma we have now,” he said, noting that the first Treatment Improvement Protocol (TIP) on methadone came out in 1993 — three decades after the treatment was first used.

Parrino stressed that he was not criticizing office-based physicians treating patients with buprenorphine under the DATA 2000 waiver. “Clearly there are a number of DATA 2000 physicians who are very thoughtful about treating their patients,” he said. “But you still don’t know what the level of service delivery is, and you surely don’t have the same regulatory oversight as there is for OTPs.”

In fact, SAMHSA wanted to avoid that level of regulatory oversight when it set the rules for DATA 2000 physicians — which is why they capped the number of patients a single physician could treat. There were concerns about patient care and about diversion. H. Westley Clark, M.D., who was director of SAMHSA’s Center for Substance Abuse Treatment from 1998 until last year, when he left the federal government, was closely aligned with this discussion. Last spring, when he spoke at the American Society of Addiction Medicine annual conference, he may have surprised many people by saying clearly that it was premature to talk about lifting the cap (see ADAW, May 4). “He said unenforceable guidelines are existentialist documents,” recalled Parrino. “He should know.”

Trade association calling for regulations

AATOD itself was founded in 1984, 20 years after methadone was first used in the treatment of opioid dependence. It was called the Northeast Regional Methadone Treatment Coalition, and it didn’t become national until 1991. Within months, Parrino met with SAMHSA about the concept of the first TIP, which in 2005 was revised to be TIP 43. So it was the OTP association itself that reached out for regulation.

A second action, also very unlike a trade association, was when the OTPs supported the transfer from the Food and Drug Administration (FDA) to SAMHSA. “The regulations become the great homogenizers,” said Parrino. “It’s no longer true that the not-for-profits are better than the for-profits, because they’re all going to be on the radar screen of the regulators.”

Regulations came after a report the GAO published 25 years ago; a stinging indictment of the FDA’s handling of OTPs, the report showed that the more effective programs were those with good staff training, therapeutic dosing and staff who aren’t revolving out the clinic.

Good management and good policy are linked, said Parrino. “Whether it’s how many patients you treat or how the patients are treated, all of this is tied together,” he said. “But it requires thought, and I believe now the atmosphere does not lend itself to very careful thought.”

For the 1990 GAO report on methadone maintenance, go to http://www.gao.gov/assets/150/148872.pdf.

Correction

In the above story on opioid treatment programs, we incorrectly cited the source guidelines on medication-assisted treatment. The guidelines will be coming from the American Society of Addiction Medicine, not the Substance Abuse and Mental Health Services Administration. The story has been corrected. We regret the error.